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Re: Dr. Mugs post# 32567

Friday, 11/19/2010 4:22:12 PM

Friday, November 19, 2010 4:22:12 PM

Post# of 59551
The DViS is a rotational radiation emitting device.....structual integrity, safety and realiabilty issues require clinical trials. Dean Janes knew 5 years ago that the DViS was a PMA candidate....but with bankruptcy glaring him in the face and a non functioning product, forced him to take the extremely long shot to no chance 510K. But the FDA for the very reasons already given above, triggered the seldomly requested 510K clinical trials. Dean Janes new in 2008 that clinial trials were ABSOLUTELY REQUIRED by IDE presentation but never performed them because he couldn't. Clinical trials would take the cat out of the bag with a non fucstioning DViS made public. But I truly believe that the DViS still doesn't work and therefore clinical trials are still out of the question. Without a fuctioning unit, IMGG is dead in the water. Has time finallycaught up with the illusive Dean Janes?